Comparison of Postoperative Quality of Recovery by Anesthetic Method in Patients Undergoing Shoulder Arthroscopy

Not Applicable

Recruiting

• Conditions: Shoulder Arthroscopy

• Registration Number: NCT06638112
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:

1. general anesthesia with preoperative brachial plexus block for intra- and postoperative analgesia

2. regional anesthesia (brachial plexus block) with intraoperative sedation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-29
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Study Start: 2024-10-30
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-10-10
• Study Completion: 2026-12-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients of age 19 years and above, scheduled for shoulder arthroscopic surgery

Exclusion Criteria

• emergency operation
• inflammation or infection at the site of nerve block administration
• inability to perform the quality of recovery questionnaire due to dementia or delirium
• severe lung disease (e.g. chronic obstructive pulmonary disease or interstitial lung disease)
• contraindication to brachial plexus block
• history of hypersensitivity or side effect to ropivacaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of recovery (QoR-15) at 48 hours post-surgery	at 48 hours post-surgery	Quality of recovery (QoR-15) at 48 hours post-surgery (0-150)

Secondary Outcome Measures

Name	Time	Method
Antiemetic administration	rom end of surgery up to 48 hours post-surgery	Antiemetic administration from end of surgery up to 48 hours post-surgery
Baseline hemidiagphramatic paralysis	On the day of surgery, before the operation	Baseline hemidiagphramatic paralysis
Postoperative hemidiagphramatic paralysis	Immediately after surgery	Postoperative hemidiagphramatic paralysis
Quality of recovery (QoR-15) on the day before surgery	on the day before surgery	Quality of recovery (QoR-15) on the day before surgery (0-150)
Quality of recovery (QoR-15) 24 hours post-surgery	at 24 hours post-surgery	Quality of recovery (QoR-15) 24 hours post-surgery (0-150)
Postoperative pain 1 hour post-surgery	at 1 hour post-surgery	Postoperative pain 1 hour post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Postoperative pain 6 hours post-surgery	at 6 hours post-surgery	Postoperative pain 6 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Postoperative pain 12 hours post-surgery	at 12 hours post-surgery	Postoperative pain 12 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Postoperative pain 24 hours post-surgery	at 24 hours post-surgery	Postoperative pain 24 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Postoperative pain 48 hours post-surgery	at 48 hours post-surgery	Postoperative pain 48 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable)
Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery	at 1 hour post-surgery	Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery	at 6 hours post-surgery	Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery	at 12 hours post-surgery	Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery	at 24 hours post-surgery	Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery
Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery	at 48 hours post-surgery	Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery
Rescue opioid analgesic administration	from end of surgery up to 48 hours post-surgery	Rescue opioid analgesic administration from end of surgery up to 48 hours post-surgery (morphine milligram equivalent, MME)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of